Why it was recalled
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Product description
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.
Lot numbers, UPCs & expiration codes
Lot #s: 1342498A, Exp. 12/2020; 1342499A, Exp. 01/2021; 1354638A, Exp. 03/2021; 1354639A, 1358274A, 1358448A, 1364618A, 1369884A, Exp. 05/2021; 1366195A, 1369885A, 1373570A, Exp. 06/2021; 1373571A, Exp. 07/2021; 1388571A, Exp. 01/2022; 1395725A, 1396585A, 1397550A, 1399389A, Exp. 04/2022; 1403885A, 1403886A, Exp. 06/2022.
Where it was sold
Nationwide in the U.S. and PR
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0069-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 28, 2020
- FDA report date
- Nov 18, 2020
- Quantity
- 133,829 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0069-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86667
- Address
- 400 Interpace Pkwy
- Code information
- Lot #s: 1342498A, Exp. 12/2020; 1342499A, Exp. 01/2021; 1354638A, Exp. 03/2021; 1354639A, 1358274A, 1358448A, 1364618A, 1369884A, Exp. 05/2021; 1366195A, 1369885A, 1373570A, Exp. 06/2021; 1373571A, Exp. 07/2021; 1388571A, Exp. 01/2022; 1395725A, 1396585A, 1397550A, 1399389A, Exp. 04/2022; 1403885A, 1403886A, Exp. 06/2022.
- Postal code
- 07054-1120
- Report date
- Nov 18, 2020
- Product type
- Drugs
- Recall number
- D-0069-2021
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 133,829 bottles
- Termination date
- Aug 26, 2021
- Reason for recall
- Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.
- Distribution pattern
- Nationwide in the U.S. and PR
- Recall initiation date
- Oct 28, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 6, 2020